Federal regulators posted three Class 2 recall records on Wednesday covering the server software behind Boston Scientific's LUX-Dx family of implanted heart monitors, after the company identified a flaw that can delay alerts about atrial fibrillation. The implanted devices themselves are working as designed, and Boston Scientific is not recommending that anyone have a monitor removed.
The distinction between the implant and the software that receives its data is the whole story here, and it is the part most likely to alarm patients unnecessarily. LUX-Dx monitors are small devices placed under the skin to watch continuously for abnormal heart rhythms. They continue to detect atrial fibrillation, store the data, and transmit it. What can be delayed is one specific notification that reaches the clinical team through the LATITUDE Clarity server.
